The US FDA releases Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products & API
On April 2023, the USFDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act” that helps to prevent and mitigate drug shortage.
The US FDA’s To produce new Cosmetic Platform and Registration Requirements for Cosmetics (MoCRA)
On March 27, 2023, The Food and Drug Administration (FDA) also referred to as ‘The Agency’ announced they will no longer accept submissions into the Voluntary Cosmetic Registration Program (VCRP).
Registration Process of Medical Devices and IVDs in Brazil
GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.
Brazil’s Anvisa changes the Importation of Controlled Drugs Regulations
Brazil’s Anvisa changes the Importation of Controlled Drugs regulations. (2023)
Anvisa Establishes New Rules for Labeling Personal Care Products, cosmetics and perfumes.
The Brazilian Health Regulatory Agency (ANVISA) issued the regulation RDC No. 752/2022 Labeling rules for Cosmetics in Brazil.
Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.
On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.
Brazil’s Anvisa Updates Medical Device Regulations with RDC 751/2022.
The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. 751/2022 on Sept. 21, 2022.
The U.S FDA Announces Pilot Program for Medical Device Submission with Health Canada
Overview On January 2023, the FDA announced that it has partnered with Health Canada to launch a joint eSTAR pilot. The pilot will allow medical device manufacturers to submit a premarket notice submission to FDA and Health Canada simultaneously. Introduction The eSTAR is an interactive PDF form that helps guide applicants through the medical device […]
The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
Starting February 2023, The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
China’s CMDE Drafts Guidelines for the Registration of Implantable Medical Devices
On January 2023, the CMDE issued Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries.
US FDA Issues Rule to Streamline Radiological Health Regulations
On January 2023, The U.S. Food and Drug Administration (FDA) published Radiological Health Regulations for Recording and Reporting Radiation Emitting Electronic Products and Performance Standards for X-ray, Laser and Ultrasonic Diagnostic Products.
US FDA Proposes Fee Increases for Certification Services on Color Additives
On January 2023, The U.S. Food and Drug Administration (FDA) has issued a proposed rule to amend color additive regulations to increase fees for certification services. ves